Ankylosing SpondylitisNCT04437394
Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients
An observational study of Ankylosing Spondylitis and Swallowing Disorder.Other Specified, run by Yavuz Atar at 1 site in Turkey (Türkiye).
Trial summary
In this study was to determine whether changes that occurred over time had an impact on the swallowing and voice functions depend of Ankylosing spondylitis patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis, Swallowing Disorder.Other Specified, Voice Alteration
- What is being tested?
- flexible endoscopic evaluation of swallowing and The analysis of voice
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2018to 30 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion.
Who may be able to join
- Diagnosed with Ankylosing spondylitis
- Person who accept to consent form
Who cannot join
- Pulmoner diseases
- Laryngeal polip or nodules
- Underwent to larynx or esophageal surgery
- Central nerve system diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof Dr Cemil Tascioglu City Hospital
Istanbul, 34384
About this study
In this study was to determine whether changes that occurred over time had an impact on the swallowing and voice functions depend of Ankylosing spondylitis patients.
Read the detailed description
This study was carried out at the University of Health Sciences Okmeydani Training and Research Hospital, Department of Otorhinolaryngology. Study was performed on 30 patients and 30 healthy subjects (Group 2) who were diagnosed with ankylosing spondylitis using modified New York criterion. The patients were asked to fill the EAT-10 and flexible endoscopic swallowing evaluation was performed. Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.
- Being tested
- flexible endoscopic evaluation of swallowing, The analysis of voice
- Keywords
- Ankylosing spondylitis, swallowing, voice
- Medical subject headings
- Spondylitis, Ankylosing, Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible endoscopic evaluation of swallowingDiagnostic test
The patients were assessment with flexible endoscopic swallowing evaluation was performed with colored pudding.
The analysis of voiceDiagnostic test
Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Study group was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion. Receives: Diagnostic Test: flexible endoscopic evaluation of swallowing; Diagnostic Test: The analysis of voice | |
| Control group | Control group was performed on 30 participants who were healthy. Receives: Diagnostic Test: flexible endoscopic evaluation of swallowing; Diagnostic Test: The analysis of voice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of swallowing
Quality of swallowing was assessed by Eating Assessment Tool inventory consisting in 10 questions that scores from 0 to 40. Low score is better, higher score is worse.
Measured: 3 months
Values of aspiration
Aspiration was assessed by aspiration penetration scale during swallowing with flexible endoscopy. The scale consisting in 8 degree that scored from 1 to 8. Higher score is worse.
Measured: 3 months
Voice analysis
Voice recordings were analyzed by PRAAT computer software. The investigator measured to shimmer, jitter and HNR voice values. The values are variation of frequency and amplitude of the sound wave. Higher value shows healthy voice for HNR parameters, lower value shows healthy voice for shimmer and jitter.
Measured: 3 months
Cervical spine situation
Cervical spine was assessed with modify stoke ankylosing spondylitis spine score that scored from 0 to 3. Low score is better and high score is worse.
Measured: 3 months
Ankylosing spondylitis disease activity
The investigator measured to disease activity with bath ankylosing spondylitis disease activity index consisting in 6 questions that scored from 0 to 10 and morning rigidity times. Low scores are better and high scores are worse.
Measured: 3 months
Secondary outcomes (1)
Demographic values
Demographic values were assessed as age (18-70) ,education and gender (male or female).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start30 Jun 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yavuz Atar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yavuz Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Yavuz Atar, Assoc. Prof., Study director, University of Health Sciences, Istanbul Prof. Dr. Cemil Tascioglu City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437394
- Sponsor's protocol ID
- 903-19/06/2018
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Creemers MC, Franssen MJ, van't Hof MA, Gribnau FW, van de Putte LB, van Riel PL. Assessment of outcome in ankylosing spondylitis: an extended radiographic scoring system. Ann Rheum Dis. 2005 Jan;64(1):127-9. doi: 10.1136/ard.2004.020503. Epub 2004 Mar 29.
PubMed 15051621Kelly AM, Drinnan MJ, Leslie P. Assessing penetration and aspiration: how do videofluoroscopy and fiberoptic endoscopic evaluation of swallowing compare? Laryngoscope. 2007 Oct;117(10):1723-7. doi: 10.1097/MLG.0b013e318123ee6a.
PubMed 17906496Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.
PubMed 19140539Ahmed EA, Atar S, Atar Y, Sari H, Anarat MEA, Salturk Z, Karaketir SG, Uyar Y, Kuru O. Evaluation of the Swallowing and Voice Functions in Ankylosing Spondylitis Patients. Dysphagia. 2022 Apr;37(2):455-462. doi: 10.1007/s00455-021-10340-1. Epub 2021 Jul 14.
PubMed 34259915
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients
- ClinicalTrials.gov ID
- NCT04437394
- Acronym / sponsor ID
- 903-19/06/2018
- Keywords
- Ankylosing spondylitis, swallowing, voice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yavuz AtarUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study was to determine whether changes that occurred over time had an impact on the swallowing and voice functions depend of Ankylosing spondylitis patients.
Detailed description
This study was carried out at the University of Health Sciences Okmeydani Training and Research Hospital, Department of Otorhinolaryngology. Study was performed on 30 patients and 30 healthy subjects (Group 2) who were diagnosed with ankylosing spondylitis using modified New York criterion. The patients were asked to fill the EAT-10 and flexible endoscopic swallowing evaluation was performed. Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: flexible endoscopic evaluation of swallowing, Diagnostic Test: The analysis of voiceStudy group was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion. |
| Control group | – | Diagnostic Test: flexible endoscopic evaluation of swallowing, Diagnostic Test: The analysis of voiceControl group was performed on 30 participants who were healthy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion.
Key inclusion criteria (2 listed)
- Diagnosed with Ankylosing spondylitis
- Person who accept to consent form
Key exclusion criteria (4 listed)
- Pulmoner diseases
- Laryngeal polip or nodules
- Underwent to larynx or esophageal surgery
- Central nerve system diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flexible endoscopic evaluation of swallowingThe patients were assessment with flexible endoscopic swallowing evaluation was performed with colored pudding. | Diagnostic test | Control group, Study group |
| The analysis of voiceVoice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program. | Diagnostic test | Control group, Study group |
Primary outcome
Quality of swallowing
Time frame: 3 months
Quality of swallowing was assessed by Eating Assessment Tool inventory consisting in 10 questions that scores from 0 to 40. Low score is better, higher score is worse.
Values of aspiration
Time frame: 3 months
Aspiration was assessed by aspiration penetration scale during swallowing with flexible endoscopy. The scale consisting in 8 degree that scored from 1 to 8. Higher score is worse.
Voice analysis
Time frame: 3 months
Voice recordings were analyzed by PRAAT computer software. The investigator measured to shimmer, jitter and HNR voice values. The values are variation of frequency and amplitude of the sound wave. Higher value shows healthy voice for HNR parameters, lower value shows healthy voice for shimmer and jitter.
Cervical spine situation
Time frame: 3 months
Cervical spine was assessed with modify stoke ankylosing spondylitis spine score that scored from 0 to 3. Low score is better and high score is worse.
Ankylosing spondylitis disease activity
Time frame: 3 months
The investigator measured to disease activity with bath ankylosing spondylitis disease activity index consisting in 6 questions that scored from 0 to 10 and morning rigidity times. Low scores are better and high scores are worse.
1 secondary outcome
Demographic values
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Results publication: PubMed 15051621Creemers MC, Franssen MJ, van't Hof MA, Gribnau FW, van de Putte LB, van Riel PL. Assessment of outcome in ankylosing spondylitis: an extended radiographic scoring system. Ann Rheum Dis. 2005 Jan;64(1):127-9. doi: 10.1136/ard.2004.020503. Epub 2004 Mar 29.
- Results publication: PubMed 17906496Kelly AM, Drinnan MJ, Leslie P. Assessing penetration and aspiration: how do videofluoroscopy and fiberoptic endoscopic evaluation of swallowing compare? Laryngoscope. 2007 Oct;117(10):1723-7. doi: 10.1097/MLG.0b013e318123ee6a.
- Results publication: PubMed 19140539Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.
- Derived from this study: PubMed 34259915Ahmed EA, Atar S, Atar Y, Sari H, Anarat MEA, Salturk Z, Karaketir SG, Uyar Y, Kuru O. Evaluation of the Swallowing and Voice Functions in Ankylosing Spondylitis Patients. Dysphagia. 2022 Apr;37(2):455-462. doi: 10.1007/s00455-021-10340-1. Epub 2021 Jul 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yavuz Atar, Assoc. Prof. study director
University of Health Sciences, Istanbul Prof. Dr. Cemil Tascioglu City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Swallowing Disorder.Other Specified, run by Yavuz Atar at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of swallowing (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04437394, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.